QA Sessional

A-type complaints does not include

• a. Purity & safety

• b. Potency

• c. Product stability

• d. Extraneous contamination, mix-ups, etc.

Responsibility of complaints lies with

• a. Production head

• b. QA head

• c. Unit head

• d. All of the above

The primary documentation to be reviewed in technical investigation stage of complaint handling involves

• a. Complaint files and the batch records

• b. Name, address, phone number and e-mail of customer

• c. Complaint sample

• d. Reserve sample

.Elements of sop are

• a. Title page

• b. Table of contents

• c. Procedure

• d. QA/QC

• e. All of the above

An audit performed by an organization on itself is

• a. Internal audit

• b. Second party audit

• c. A third party audit

• d. None of the above

OOS stands for

• a. Out of specification

• b. Out of supervisor

• c. Others of specification

• d. Out of static

All deviation, investigation, and oos report should be reviewed as part of

• a. Batch master review

• b. Certificate of analysis

• c. Batch record review

Work instruction may cover many of the following details

• a. Material handling requirements

• b. Safety alerts for the employees

• c. Equipment maintenance procedures

• d. All of the above

Principle of auditing

• a. Fail presentation

• b. Evidence based approach

• c. Due professional care

• d. All of above

According to USFDA guidelines the three stages if process validation involve

• a. Process design

• b. Process qualification

• c. Continued process verification

• d. All of the above